VMA Motion Normalizer

GUDID 00868579000247

VMA Motion Normalizer (Console, Table, and Upright assemblies)

ORTHO KINEMATICS, INC.

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 00868579000247
• NIH Device Record Key: 87e94e30-5594-4e6b-845d-8181dad3a255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VMA Motion Normalizer
• Version Model Number: 3
• Company DUNS: 932053221
• Company Name: ORTHO KINEMATICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5123345490
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868579000247 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-01-31

Devices Manufactured by ORTHO KINEMATICS, INC.

• 00868579000216 - VMA DataLink Software: 2019-05-23
• 00868579000223 - VMA DataLink Software: 2019-05-23 VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
• 00868579000230 - VMA Image Acquisition Software: 2019-05-23 VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
• 00868579000261 - Profile-ESP Bolster: 2019-03-11 The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA S
• 00868579000278 - Profile-ESP Radiographic marker: 2019-03-11 The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate
• 00868579000209 - VMA: 2019-02-21
• 00868579000247 - VMA Motion Normalizer: 2019-02-21VMA Motion Normalizer (Console, Table, and Upright assemblies)
• 00868579000247 - VMA Motion Normalizer: 2019-02-21 VMA Motion Normalizer (Console, Table, and Upright assemblies)